AVKARE Fexofenadine Hydrochloride Tablets Recalled for Failed Stability Specifications
AVKARE Inc. is recalling Fexofenadine Hydrochloride Tablets USP 180 mg because the product failed stability specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AVKARE Inc. is voluntarily recalling 5,953 bottles of Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50. The recall is being conducted because the product failed stability specifications.
The affected product was distributed nationwide in the U.S. The specific lot numbers involved are 067180011A, 067180012A (Expiration 04/2021), and 06718027B1 (Expiration 09/2021).
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The U.S. Food and Drug Administration has classified this recall as Class II.
The recalled product
- Product
- AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Antihistamine
- Affected units
- 5,953
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: 067180011A
- 067180012A
- Exp. 04/2021
- 06718027B1 Exp. 09/2021
Distribution
Distributed nationwide across the United States.
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